Abstract：
Background: A non-invasive ventilation (NIV) mask has been designed to deliver NIV with expiratory washout (EW) to improve efficacy of ventilation by optimizing clearance of expired gases from the anatomic dead-space. This study compared the performance and comfort of a novel investigational mask with EW with a conventional mask during NIV therapy.Methods: In this pilot cross-over study, participants with severe stable chronic obstructive pulmonary disease (COPD) attended a single visit to receive bi-level NIV through two masks; the investigational mask with EW, and a conventional mask. The order of mask use was randomly allocated, and each mask was used for 60-minutes with a 30-to-60-minute washout in between. The primary outcome was transcutaneous carbon dioxide (PtCO2) at 60 minutes. Other physiologic and NIV device variables were also assessed.Results: The mean difference [95% CI] in the PtCO2 between the investigational and conventional masks at 60 minutes, adjusted for baseline, was -0.74 mmHg [-2.81 to 1.33, P=0.45]. The investigational mask with EW elicited a lower tidal volume (-128.7 mL [-190.0 to -67.3], P<0.001) and minute ventilation (-2.28 L·min-1 [-3.12 to -1.43], P<0.001), and a higher leak (7.96 L·min-1 [4.39 to 11.54], P<0.001), than the conventional mask. There were no significant differences in other physiological responses or ratings of dyspnoea or comfort.Conclusions: NIV therapy delivered using a novel mask with EW was similarly effective at reducing PtCO2, while the delivered tidal volume and minute ventilation were significantly lower, when compared to a conventional mask in participants with severe COPD.
摘要：
背景：设计了一种无创通气（NIV）面罩，可通过呼气冲洗（EW）来输送NIV，以通过优化从解剖死腔中清除呼出气体来提高通气效率。这项研究比较了在NIV治疗期间，具有EW的新型研究性口罩与常规口罩的性能和舒适度。方法：在这项试点交叉研究中，患有严重稳定期慢性阻塞性肺疾病（COPD）的参与者参加了一次访问，通过两个口罩接受了双水平NIV；带有EW的研究性口罩，一个传统的面具。口罩的使用顺序是随机分配的,每个面罩使用60分钟，其间有30到60分钟的冲洗时间。主要结果是在60分钟时经皮二氧化碳(PtCO2)。还评估了其他生理和NIV装置变量。结果：60分钟时，研究性口罩和常规口罩之间的PtCO2平均差[95％CI]，针对基线进行了调整，为-0.74mmHg[-2.81至1.33，P=0.45]。带有EW的研究性口罩引起较低的潮气量（-128.7mL[-190.0至-67.3]，P<0.001）和分钟通气量（-2.28L·min-1[-3.12至-1.43]，P<0.001)，和更高的泄漏（7.96L·min-1[4.39至11.54]，P<0.001)，比传统的面具。其他生理反应或呼吸困难或舒适度等级没有显着差异。结论：使用带有EW的新型面罩进行的NIV治疗在降低PtCO2方面同样有效，而递送的潮气量和分钟通气量则显着降低，与重度COPD参与者的常规口罩相比。
